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Detection of Circulating Endothelial Progenitors Cells (EPCs) in Non-small Cell Lung Cancer (NSCLC) (CBNPC:PCE)

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ClinicalTrials.gov Identifier: NCT00826683
Recruitment Status : Completed
First Posted : January 22, 2009
Last Update Posted : August 22, 2016
Sponsor:
Information provided by (Responsible Party):
University Hospital, Limoges

Tracking Information
First Submitted Date  ICMJE January 9, 2009
First Posted Date  ICMJE January 22, 2009
Last Update Posted Date August 22, 2016
Study Start Date  ICMJE March 2009
Actual Primary Completion Date December 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 20, 2009)
Number of EPCs in peripheral blood from NSCLC patients. Comparison with healthy non-smokers patients and smokers with COPD. [ Time Frame: at the end of the first step of the study (2 months after the beguening of the study) ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00826683 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 20, 2009)
Characterization of EPCs by primary cultures. Correlation between initial EPCs and VEGF concentration in COPD and NSCLC patients Overall survival in NSCLC patients in relation to EPCs initial numeration [ Time Frame: at he end of the study (10 months after the beguening of the study) ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Detection of Circulating Endothelial Progenitors Cells (EPCs) in Non-small Cell Lung Cancer (NSCLC)
Official Title  ICMJE Detection of Circulating Endothelial Progenitor Cells (EPCs) in Peripheral Blood From Non-small Cell Lung Cancer Patients
Brief Summary Bone-marrow-derived progenitor cells (EPCS) play an important role in neovascularization and tumor growth. In lung cancer, angiogenesis is an important event in mechanisms of tumor proliferation and metastasis. Recent evidences suggest that EPCS can be recruited and differentiate in mature endothelial cells to form new blood vessels. The role of EPCs in NSCLC is unclear. In contrast, angiogenic drugs are proposed combined to systemic chemotherapy in NSCLC. The aim of this study is to identify EPCs in peripheral blood from patients with NSCLC, by comparison to Chronic Pulmonary Obstructive Disease (COPD), an inflammatory disease.
Detailed Description

The aim of this study is to study blood circulating levels bone-marrow-derived progenitor cells (EPCS).

In a first phase, EPCs will be detected in healthy non-smokers volunteers to validate flow cytometry method (n=25). In addition, EPC will e characterized by primary cultures to analyze EPC-specific markers.

In a second phase, EPCs will detect in peripheral blood from 50 patients with Chronic Obstructive Pulmonary Disease (COPD) and 50 patients with non-small cell lung cancers (NSCLC). Primary cultures will be made to confirm EPCS isolation.

Methods: EPCs will be numerated by flow cytometry using CD133, CD146, CD34, CD45 and VEGFR2 antibodies. Primary cultures will be used to identify EPCs at 5-days culture by the same markers. In addition, for BPCO et NSCLC patients, Vascular endothelial cell growth factor (VEGF) concentration will be measured in peripheral sera by ELISA commercial test.

Overall survival will be analyzed for NSCLC in function of initial EPCs concentration. Correlation will be studied between initial VEGF serum concentration and EPCs level.

This study focus on the possibility that EPC determination in peripheral blood could be used as a surrogate marker of standard or antiangiogenic treatment in NSCLC.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE
  • Non-Small Cell Lung Cancer
  • Chronic Obstructive Pulmonary Disease
Intervention  ICMJE Biological: Enumeration of endothelial cell progenitor in peripheral blood by flow cytometry, Endothelial cell progenitor characterization by primary cell cultures
Other Names:
  • Characterization of the EPC by the primary cultures,correlation between initial
  • EPCs and VEGF concentration
Study Arms  ICMJE
  • Control group of healthy subjects
    Control group of healthy subjects : simple blood analysis of EPCs
    Intervention: Biological: Enumeration of endothelial cell progenitor in peripheral blood by flow cytometry, Endothelial cell progenitor characterization by primary cell cultures
  • Active Comparator: COPD
    COPD: one initial blood sample and simple clinical follow-up
    Intervention: Biological: Enumeration of endothelial cell progenitor in peripheral blood by flow cytometry, Endothelial cell progenitor characterization by primary cell cultures
  • Active Comparator: NSCLC
    NSCLC: one initial blood sample and usual clinical follow-up
    Intervention: Biological: Enumeration of endothelial cell progenitor in peripheral blood by flow cytometry, Endothelial cell progenitor characterization by primary cell cultures
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 2, 2009)
140
Original Estimated Enrollment  ICMJE
 (submitted: January 20, 2009)
125
Actual Study Completion Date  ICMJE January 2011
Actual Primary Completion Date December 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Signed written consent
  • Subject > 18 year old
  • No precedent therapy for cancer
  • Non-smoker healthy subject or current smoker COPD patients or NSCLC patients

Exclusion Criteria:

  • Small-cell lung cancer patient
  • Radiotherapy, chemotherapy or target therapy for NSCLC
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00826683
Other Study ID Numbers  ICMJE I08002
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University Hospital, Limoges
Study Sponsor  ICMJE University Hospital, Limoges
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Boris MELLONI, Professor Service de pneumologie,chu Limoges
PRS Account University Hospital, Limoges
Verification Date October 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP